Medical devices client in the North West is looking for a regulatory affairs consultant for to work on technical files dossier and a commercial product which has now been re-classed as a medical device.

You will be;

- Working on the development, verification, validation of, and post-market support for the product.

- Regulatory submissions/registrations/compliance with US and EU

- Creating and reviewing Technical Files/CFR 820/21 part 11

- Make sure the product is fully compliant.

You MUST have experience with the above and extensive regulatory affairs experience within medical device companies.